Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis
28. august 2018 oppdatert av: StemGenex
Autologous Adipose Stromal Vascular Fraction Outcomes in Osteoarthritis Research Study
The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on joint pain and functionality in people with Osteoarthritis (OA).
SVF contains components with "regenerative" properties, including stem cells that have shown promise for ameliorating specific disease conditions.
This study is designed to evaluate joint pain and functionality changes in individuals with OA for up to 12 months following SVF treatment.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Observasjonsmessig
Registrering (Forventet)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Diego, California, Forente stater, 92121
- Rekruttering
- StemGenex
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Ta kontakt med:
- Telefonnummer: 855-742-7836
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Community Sample
Beskrivelse
Inclusion Criteria:
- Fluent in English
- Over the age of 18
- Diagnosed with OA of the knee and/or hip
- Scheduled for intravenous and intra-articular administrations of autologous SVF
- Capable of understanding and willing to sign informed consent
- Willing and able to complete brief phone interviews
- Willing and able to complete online surveys
Exclusion Criteria:
- Co-morbidity with an autoimmune disorder
- Pregnant, may become pregnant, or breastfeeding
- Subjects for which baseline data is not available
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Overall Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0)
Tidsramme: Baseline, 12 months
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The change from baseline over the course of 12 months using participants' assessment of their knee and associated problems.
Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12).
Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.
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Baseline, 12 months
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Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0)
Tidsramme: Baseline, 12 months
|
The change from baseline over the course of 12 months using participants' assessment of their hip and associated problems.
Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12).
Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.
|
Baseline, 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Knee Pain at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Pain Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in knee pain from baseline to month 12 using the KOOS pain subscale.
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Baseline, Month 12
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Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The ADL Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in function in daily living from baseline to month 12 using the KOOS ADL subscale.
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Baseline, Month 12
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Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Sport/Rec Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in sport and recreation from baseline to month 12 using the KOOS sport/rec subscale.
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Baseline, Month 12
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Change from Baseline in Knee Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Knee Related Quality of Life Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in knee related quality of life from baseline to month 12 using the KOOS QOL subscale.
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Baseline, Month 12
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Change from Baseline in Other Knee Symptoms at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Other Symptoms Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in other knee symptoms from baseline to month 12 using the KOOS other symptoms subscale.
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Baseline, Month 12
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Change from Baseline in Hip Pain at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Pain Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in hip pain from baseline to month 12 using the HOOS pain subscale.
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Baseline, Month 12
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Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The ADL Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in function in daily living from baseline to month 12 using the HOOS ADL subscale.
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Baseline, Month 12
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Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Sport/Rec Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in function in sport and recreation from baseline to month 12 using the HOOS sport/rec subscale.
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Baseline, Month 12
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Change from Baseline in Hip Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The QOL Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in hip related quality of life from baseline to month 12 using the HOOS QOL subscale.
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Baseline, Month 12
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Change from Baseline in Other Hip Symptoms at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Other Symptoms Subscale
Tidsramme: Baseline, Month 12
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Participant assessment in the change in other hip symptoms from baseline to month 12 using the HOOS other symptoms subscale.
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Baseline, Month 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2014
Primær fullføring (Forventet)
1. september 2019
Studiet fullført (Forventet)
1. september 2019
Datoer for studieregistrering
Først innsendt
13. september 2014
Først innsendt som oppfylte QC-kriteriene
13. september 2014
Først lagt ut (Anslag)
16. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SVF01OA
- ASCOA-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .